A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants

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Janssen

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Erdafitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03066687
CR108289
42756493EDI1006 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • If a woman, must be not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 12 months and a serum follicle stimulating hormone [FSH] >40 International Units Per Liter [IU/L]); or surgically sterile
  • If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of Period 1 and Period 2
  • If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after the last study drug administration
  • Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18 and 32 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kg
  • Non-smoker for at least 6 months before first study drug administration

Exclusion criteria

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • History or current evidence of ophthalmic disorder, such as central serous retinopathy (CSR) or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
  • Clinically significant abnormal values for hematology, serum chemistry, or urinalysis at screening as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen and hormonal replacement therapy, within 14 days before the first dose of the study drug is scheduled until completion of the study

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Treatment Sequence 1: Erdafitinib 9 mg
Experimental group
Description:
Participants will receive 9 milligram (mg) dose of erdafitinib under fasted condition [Treatment A] in Period 1, and under fed (with high-fat and high-calorie breakfast) condition [Treatment B] in Period 2. Each Treatment Period will be separated by a washout of at least 28 days.
Treatment:
Drug: Erdafitinib
Treatment Sequence 2: Erdafitinib 9 mg
Experimental group
Description:
Participants will receive 9 mg dose of erdafitinib under fed (high-fat and high-calorie breakfast) condition [Treatment B] in Period 1, and under fasted condition [Treatment A] in Period 2. Each Treatment Period will be separated by a washout of at least 28 days.
Treatment:
Drug: Erdafitinib

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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